The objective of this study is to determine the efficacy of INC424 as assessed by reduction in spleen volume in patients with primary myelofibrosis (MF), post-polycythemia vera (PV) MF, or post-essential thrombocythemia (ET) MF. The safety and tolerability of INC424 and the effects of INC424 on patient reported outcomes and the duration of response as assessed by reduction in spleen volume will also be assessed.

Ruxolitinib is taken twice daily, unless instructed. ﻿Starting dose 15 mg BID for patients with baseline platelet count of 100,000/μL to 200,000/μL (inclusive) or 20 mg BID for those with baseline platelet count >200,000/μL (approximately 12 hours apart: morning and night), to be increased or decreased per standardized dosing paradigm.

Drug: Ruxolitinib

INC424 Tablet for oral use, provided in 5 mg bottles. The dosage strength is 5 mg/tablet INC424 phosphate (free base equivalent). Medication labels will be in the local language and comply with the legal requirements of each country. equivalent).

Should discontinue any prior or ongoing treatment for myelofibrosis prior to entering the study

Had no prior treatment with another JAK inhibitor

Exclusion Criteria:

Does not have adequate liver or kidney function (as measured by blood tests)

Has an active infection (bacterial, viral, etc.)

Has active hepatitis A, B, or C or positive for HIV

Has another cancer that needs active intervention

Had a history of bleeding disorder

Had a history of very low platelet counts (as measured by blood tests) not related to treatment of MF

Had radiation of the spleen within 1 year of joining the study

Does not have adequate heart function

Sufficient time has elapsed between stopping previous treatment for MF and joining the study

Females who are pregnant or breast-feeding

Not able to sign informed consent

Has any other active medical conditions that the doctor deems may compromise your safety or ability to join in the study

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392443